I cover cardiology news for CardioExchange, a social media website for cardiologists published by the New England Journal of Medicine. I was the editor of TheHeart.Org from its inception in 1999 until December 2008. Following the purchase of TheHeart.Org by WebMD in 2005, I became the editorial director of WebMD professional news, encompassing TheHeart.Org and Medscape Medical News. Prior to joining TheHeart.Org, I was a freelance medical journalist and wrote for a wide variety of medical and computer publications. In 1994-1995 I was a Knight Science Journalism Fellow at MIT. I have a PhD in English from SUNY Buffalo, and I drove a taxicab in New York City before embarking on a career in medical journalism. You can follow me on Twitter at: @cardiobrief.

Following Earlier Recall, Ranbaxy Halts Manufacturing Atorvastatin

Ranbaxy, the often-troubled manufacturer of generic drugs, will temporarily stop manufacturing generic atorvastatin. On November 9, 2012 the company announced a voluntary recall of some lots of atorvastatin because of possible contamination with glass particles. An FDA statement today said that Ranbaxy will discontinue making the drug “until it has thoroughly investigated the cause of the glass particulates and remedied the problem.”

To date, no reports of harm from the contamination have been received by the FDA. Both FDA and Ranbaxy believe there is only a low likelihood that there will be adverse events related to the problem.

The FDA said it does not anticipate a shortage of atorvastatin because of the recall, but that it “is working with other manufacturers of atorvastatin to ensure adequate market supply.”

Here is the FDA statement:

FDA Statement on the Ranbaxy Atorvastatin Recall

[11/29/2012] On Nov. 9, 2012, Ranbaxy Pharmaceuticals informed its customers of a voluntary recall of certain lots of the company’s 10mg, 20mg, and 40mg dosage strengths of atorvastatin tablets. The lots of atorvastatin, packaged in bottles of 90 and 500 tablets, are being recalled due to possible contamination with very small glass particles similar to the size of a grain of sand (less than 1 mm in size).

Due to this quality issue, Ranbaxy has decided to stop manufacturing atorvastatin until it has thoroughly investigated the cause of the glass particulates and remedied the problem. Based on the information from Ranbaxy and from the FDA’s initial assessment, the possibility of adverse events related to the recalled product appear to be low, and if any adverse events are experienced, they would be temporary.

At this time, we have not received any reports of patient harm due to glass particulates that may be in the recalled product.

Consumers who are concerned that they may have received a recalled product should consult with their pharmacist where they bought the product to confirm whether they received a recalled product, should stop taking the product if it was recalled, and should consult with their pharmacist or physician about how to obtain an alternative product.

Americans expect and deserve safe, effective, and high quality medications. The FDA continues to evaluate information associated with this recall and will notify the public as new information becomes available. The agency will continue to oversee the recall process, and work with the Ranbaxy to resolve these pharmaceutical quality issues.

Atorvastatin is a widely used cholesterol lowering medication that is available from several manufacturers. While there is no anticipated drug shortage for any of the affected lots or strengths, the FDA is proactively monitoring the situation for the possibility of a shortage. The FDA is working with other manufacturers of atorvastatin to ensure adequate market supply in order to avoid shortages of atorvastatin as a result of this ongoing recall.

If patients experience any adverse events, they should contact their health care provider. Health care professionals and consumers can also report adverse events to MedWatch, FDA’s adverse event reporting program:

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